Ropinirole Tablet, Film Coated, Extended Release
NDC Package 46708-264-71

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ropinirole tablets is  Ropinirole extended-release tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-264 and is authorized under FDA application ANDA202786.

Identification & Billing

NDC Package Code
46708-264-71
Package Description
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
46708-264
11-Digit Billing Format
46708026471
RxNorm Crosswalk
  • RxCUI: 799054 - rOPINIRole 8 MG 24HR Extended Release Oral Tablet
  • RxCUI: 799054 - 24 HR ropinirole 8 MG Extended Release Oral Tablet
  • RxCUI: 799054 - ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 799054 - ropinirole 8 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 799055 - rOPINIRole 2 MG 24HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Ropinirole
Non-Proprietary Name
Ropinirole
Substance Name
Ropinirole Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ROPINIROLE HYDROCHLORIDE 6 mg/1
Pharmacologic Class
Usage Information
 Ropinirole extended-release tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA202786
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-14-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (46708-264). Click a package code to view its specific billing and regulatory data.

46708-264-10
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON
46708-264-30
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
46708-264-31
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
46708-264-90
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
46708-264-91
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 46708-264-71 identifies a specific commercial package of 500 tablet, film coated, extended release in 1 bottle of Ropinirole, a human prescription drug labeled by Alembic Pharmaceuticals Limited. This tablet, film coated, extended release is formulated for oral use and contains ropinirole hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Alembic Pharmaceuticals Limited on March 14, 2013. The current certification is valid through December 31, 2026.

How is this Alembic Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708026471. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
46708-264-71
11-Digit CMS (5-4-2)
46708-0264-71

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.